Analyses of COMFORT 1 & 2 studies of Jakavi for Myelofibrosis-Novartis

Novartis announced that patients with Myelofibrosis initially randomized to treatment with Jakavi (ruxolitinib) lived longer than those randomized to treatment with placebo or conventional therapy, as described in several analyses from the Phase III COMFORT-I and COMFORT-II studies. Results are being presented at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans, LA.

A Pooled Overall Survival Analysis of the COMFORT Studies (abstract #2820). In the COMFORT-I and -II studies, risk of death at three years was reduced by 35% in patients initially randomized to treatment with Jakavi compared to patients randomized to the control group (HR = 0.65; 95% CI, 0.46-0.90; P = 0.01). Patients with high risk Myelofibrosis who were initially randomized to treatment with Jakavi had an estimated survival similar to patients with intermediate-2-risk Myelofibrosis in the control group. Additionally, among all patients in the study, bigger spleen size before treatment was associated with higher risk of death (HR = 1.09; 95% CI, 1.03-1.15; P = 0.003).